Methodology Archives - Implementation Science at UW

✪ Rigorous projects and grants integrating human-centered design and implementation science: 8 tips for success

Abstract:

Background

Researchers and funders increasingly see potential for integrating human-centered design (HCD) and implementation science (IS) approaches to enhance the design and uptake of health interventions and implementation strategies. These approaches offer complementary strengths. HCD prioritizes developing compelling, intuitive, and adoptable innovations grounded in user and contextual needs; IS focuses on ensuring evidence-based practices reach and work for their intended populations. Integrating HCD and IS creates challenges that existing IS proposal writing guidelines do not address. HCD’s inherent uncertainty–since final designs are developed through iteration rather than pre-determined–can unsettle researchers and funders accustomed to more defined endpoints. Variation in how HCD is understood adds further difficulty when collaborating across disciplines or communicating with funders. There are currently no published recommendations to help researchers design strong studies integrating HCD and IS and communicate them effectively to funders.

Discussion

We present tips to support both rigorous study design and effective proposal writing that integrate HCD and IS. This draws from our experiences leading, supporting, and reviewing both funded and unfunded projects. Our considerations are informed primarily by experiences with teams in the United States in the mental health and behavioral health domains; however, we have found our findings also apply to projects globally and in other health sectors. Our intent is that this guide will advance good research that leverages both approaches and is viable for funding. We also hope that the tips will support funders in developing solicitations and evaluating proposals.

Conclusion

There is untapped potential for innovative health research integrating HCD and IS, but realizing it requires both rigorous study design and an ability to attract funding. We offer practice guidance to help researchers and funders develop quality projects and proposals, and we encourage others to build on these recommendations.

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✪ Design and method considerations for equity-centered implementation science and practice: A PEDALs approach

Abstract:

The persistent "know-do gap"—the lag between the development of evidence-based practices (EBPs) and their routine use in health systems—remains a barrier to achieving global health equity. Implementation science offers a pathway to bridge this gap, but without an explicit equity focus, it risks reinforcing existing disparities. In this perspective, we propose an equity-centered adaptation of the PEDALs model (Problem, Evidence-based practice, Determinants, Action, Long-term use, and scale) to guide more just and context-sensitive implementation efforts in global health.

We describe how each stage of PEDALs can be used to embed equity considerations in implementation research and practice. These include identifying root causes of inequity-linked health problems (P), using both scientific and practice-based evidence while adapting or de-implementing interventions (E), engaging marginalized voices when analyzing barriers and facilitators (D), co-designing contextually grounded implementation strategies (A), and measuring long-term implementation outcomes through an equity lens (L), including attention to scalability, iterative learning, and proper design and methods (s). We highlight methodological considerations—such as hybrid designs, embedded and workflow-based research, and rapid and participatory methods—that support timely, relevant, and equitable implementation. Our model builds on the concept of “radical incrementalism” to emphasize steady, equity-driven change that is responsive to diverse settings, especially in low- and middle-income countries. This modified PEDALs-based approach offers a practical structure for design and methodological considerations in advancing equity-centered implementation science.

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✪ A pragmatic approach to estimating the cost to deliver and participate in implementation strategies

Abstract:

The Healing Experiences of Adversity Among Latinos (HEALthy4You; H4Y) study was a multi-sector partnership between an academic research institution, a Federally Qualified Health Center (FQHC), and a multi-sector collective impact coalition focused on childhood obesity prevention. The goal of HEALthy4You was to develop community-centered and culturally appropriate precision interventions within FQHCs for Latino families to address predictors of adverse child experiences and treat childhood obesity. A multidisciplinary and multi-sector research, clinical, and community team (N = 29) was formed in September 2020 to co-design the study, which launched in June 2022. The team utilized a co-creation approach combined with the Exploration, Preparation, Implementation, and Sustainment framework to facilitate a collaborative design process. We conducted an internal and retrospective process evaluation in March 2023 to identify antecedents and situational factors associated with project formation, with a focus on understanding tensions and challenges with a broad partnership structure. We outline the team's co-creation process and describe internal challenges and pitfalls that emerged when developing the project. We sought to better understand the impact of differing perspectives, priorities, and goals between disciplines, sectors, and roles; differing approaches to evidence and evidence production; and team strategies to mitigate and manage competing pressures and priorities. This case report describes lessons learned, intending to share insights to support future development of best practices in project, partner, and team formation between researchers, clinicians, and community members. More specifically, these lessons could help inform community-led research endeavors between academic institutions, FQHCs, and community-based organizations (CBOs).

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Conducting an implementation intervention study with American Indian and Alaska Native communities: Methodological considerations

✪ Methods for community-engaged data collection and analysis in implementation research

Abstract:

Background

Community engagement is widely recognized as critical to successful and equitable implementation of evidence-based practices, programs, and policies. However, there are no clear guidelines for community involvement in data collection and analysis in implementation research.

Methods

We describe three specific methods for engaging community members in data collection and analysis: concept mapping, rapid ethnographic assessment, and Photovoice. Common elements are identified from a case study of each method: 1) selection and adaptation of evidence-based strategies for improving adolescent HPV vaccine initiation rates in disadvantaged communities, 2) strategies for implementing medication for opioid use disorders among low-income Medicaid enrollees during natural disasters, and 3) interventions to improve the physical health of adults with severe mental illness living in supportive housing.

Results

In all three cases, community members assisted in participant recruitment, provided data, and validated preliminary findings created by researchers. In the Photovoice case study, community members participated in both data collection and analysis, while in the concept mapping, community members also participated in the initial phase of organizing and prioritizing evidence-based strategies during the data analysis.

Conclusions

Community involvement in implementation research data collection and analysis contributes to greater engagement and empowerment of community members and validation of study findings. Use of methods that exhibit both scientific rigor and community relevance of implementation research also contributes to greater community investment in successful implementation outcomes. Nevertheless, the case studies point to the importance and efficiency of the division of labor embedded in community-engaged implementation research. Building capacity for community members to assume greater roles in obtaining and organizing data for preliminary analysis prior to interpretation is recommended.

Contributions to the literature

Guidelines exist for conducting community engaged research but provide no clear instructions for community involvement in data collection and analysis.
This paper examines the potential of community engaged data collection and analysis in implementation research through case studies of concept mapping, rapid ethnographic methods, and Photovoice.
Community involvement in implementation research data collection and analysis contributes to greater engagement and empowerment of community members, validation of study findings, and commitment to successful implementation outcomes.

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✪ Mechanism-Based Middle-Range Theories: Using Realist Syntheses to Reconcile Specificity to Context and Generalizability

Abstract:

Realist synthesis is a recognized methodological approach to evidence synthesis to inform evidence-based health policy and practice. The implicit assumption behind research synthesis is that the evidence it generates should be generalizable––drawing broad inferences from specific observations. While this understanding is generally shared among social scientists, tensions exist between having generalizable evidence and how this evidence can be useful in specific contexts. This paper considers the role of mechanism-based middle-range theories obtained from realist synthesis in bridging specificity to context and generalizability. Retroductive theorizing in realist synthesis helps to identify ideas about mechanisms related to the phenomenon embedded in the social and organizational contexts that could, in principle, have a much broader application. Also, because mechanism-based middle-range theories are linked to contextual features, they capture contextual nuances to enhance evidence implementation. We conclude that middle-range mechanisms provide an opportunity to achieve generalizability and contextualization in implementation science.

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✪ A framework for designing hybrid effectiveness-implementation trials for digital health interventions

Abstract:

This article proposes methods for designing randomized controlled trials studying the implementation and effectiveness of digital interventions, meaning websites or applications ("apps") that patients use in healthcare. Deploying digital interventions for behavioral health differs from implementing traditional interventions such as medications or human-delivered therapy. Prior trial design guidance has ignored the existence of international governmental evidence standards, has paid insufficient attention to implementation reporting guidelines, and has not described methods for empirically testing the approach for organizing the delivery of digital interventions.

This framework for designing hybrid effectiveness-implementation trials of digital behavioral health interventions helps researchers articulate research questions that matter to decision-makers and meaningfully contribute to implementation. The framework outlines three phases: 1) frame effectiveness and implementation questions in terms of the digital intervention components, types of clinical support for the digital intervention, and specific strategies for implementing the digital intervention; 2) define and delineate actors, activities, action targets, dose, temporality, and outcomes to maximize inference and reproducibility; and 3) specify trial design features used for hybrid classification.

We illustrate the utility of this framework with two effectiveness-implementation studies of digital interventions for substance use. This framework can help researchers decide on appropriate methodology and help decision-makers apply findings.

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✪ Applying the Cognitive Walkthrough for Implementation Strategies methodology to inform the redesign of a selection-quality implementation toolkit for use in schools

Abstract:

Background

Implementation strategies are key to enhancing the translation of new innovations but there is a need to systematically design and tailor strategies to match the targeted implementation context and address determinants. There are increasing methods to inform the development and tailoring of implementation strategies to maximize their usability, feasibility, and appropriateness in new settings such as the Cognitive Walkthrough for Implementation Strategies (CWIS) approach. The aim of the current project is to apply the CWIS approach to inform the redesign of a multifaceted selection-quality implementation toolkit entitled Adoption of Curricular supports Toolkit: Systematic Measurement of Appropriateness and Readiness for Translation in Schools (ACT SMARTS) for use in middle and high schools.

Methods

We systematically applied CWIS as the second part of a community-partnered iterative redesign of ACT SMARTS for schools to evaluate the usability and inform further toolkit redesign areas. We conducted three CWIS user testing sessions with key end users of school district administrators (n = 3), school principals (n = 6), and educators (n = 6).

Results

Our CWIS application revealed that end users found ACT SMARTS acceptable and relevant but anticipate usability issues engaging in the ACT SMARTS process. Results informed the identification of eleven usability issues and corresponding redesign solutions to enhance the usability of ACT SMARTS for use in middle and high schools.

Conclusions

Results indicated the utility of CWIS in assessing implementation strategy usability in service of informing strategy modification as part of our broader redesign to improve alignment with end user, end recipient, and setting needs. Recommendations regarding the use of this participatory approach are discussed.

Contributions to the literature

The current case study adds to the nascent literature applying the Cognitive Walkthrough for Implementation Strategies (CWIS) method as part of a larger implementation project, including one of the first independent applications outside of the CWIS method developers.
The current case study illustrates the impact and utility of the CWIS method for designing and tailoring implementation strategies.
This case study provides further guidance and recommendations for the application of CWIS to future implementation projects.

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✪ Balancing realist review outputs with the needs of policymakers and practitioners

Abstract:

A realist review is a theory-driven approach to synthesizing evidence based on the realist philosophy of science. Realist reviews are conducted to provide the policy and practice community with a rich, detailed and practical understanding of complex social interventions that will likely be of much more use to them when planning and implementing programmes. Robust realist reviews must balance philosophical engagement, methodological rigour and relevance to practice. Nevertheless, they have been criticized for being more philosophically inclined and less methodologically robust, with findings that have little implication for practice. Using the philosophy/epistemology➔ methodology➔ theory➔ practice concept flow, we report how we balanced philosophical principles and practical insights in a recently conducted realist review on participatory practices that impact the benefits of non-communicable disease research and interventions in low- and middle-income countries. If realist reviews are not comprehensible enough for these practitioners, their utility and relevance may suffer from being limited to a specialist cohort of academics. We propose that realist review findings and outputs must be framed and communicated to meaningfully engage practitioners without undertaking translational efforts.

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✪ Implementation of a bilingual and bicultural navigation program for Hispanic children with traumatic brain injuries

Abstract:

Background

Traumatic brain injury (TBI) disproportionately affects Hispanic children, with higher rates of severe injuries and worse outcomes compared to non-Hispanic White children. Patient navigation has shown effectiveness in improving health outcomes among Hispanic populations. However, culturally tailored navigation programs for pediatric TBI are lacking, and knowledge gaps remain regarding contextual factors influencing the implementation of these programs. This study examined factors that facilitate or hinder the implementation of a bilingual and bicultural navigation program for caregivers of Hispanic children with TBIs.

Methods

In-depth interviews were conducted with 12 personnel involved in implementing the 1st Brain Injury Education and Outpatient Navigation (1st BIEN) program across four states. Directed content analysis was used based on the Consolidated Framework for Implementation Research (CFIR) to guide the development of the interview guide and data analysis.

Results

Key facilitators included the program’s adaptability to patient needs, bilingual/bicultural patient navigator’s skills, and alignment with organizational values. Barriers included restrictive healthcare regulatory policies hindering interinstitutional work, incomplete medical records, and gaps in behavioral support training.

Discussion

These findings offer insights for optimizing the implementation of patient navigation programs in pediatric TBI care, potentially improving access to care and reducing disparities for Hispanic children with brain injuries.

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Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science Communications

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Background

Discussion

Conclusion

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Read the full text in the open access journal Global Health Research and Policy

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Read the full text in the open access journal Implementation Science

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Subscription Required for Full Text Access

Read the full text in the subscription access journal Contemporary Clinical Trials

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✪ Open Access

Read the full text in the open access journal Implementation Science Communications

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Background

Methods

Results

Conclusions

Contributions to the literature

Authors:

✪ Open Access

Read the full text in the open access journal Qualitative Health Research

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✪ Open Access

Read the full text open access in the journal Annals of Epidemiology

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✪ Open Access

Read the full text in the open access journal Implementation Science Communications

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Background

Methods

Results

Conclusions

Contributions to the literature

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✪ Open Access

Read the full text in the open access journal Health Policy and Planning

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✪ Open Access

Read the full text in the open access journal Brain Injury

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Background

Methods

Results

Discussion